BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11102094 · Received December 31, 2020

    Report

    Report Number
    1920898-2020-01781
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 2, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/28/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (2) 3/10CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 0090638. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR OUT OF SPEC SHIELD PULL. ROOT CAUSE: ROOT CAUSE COULD NOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO HUB SEPARATED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328291, BATCH NO. 0090638. IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM SYRINGE. VERBATIM: FROM PHONE CALL ON 2020-12-03 12:29:32: CONSUMER REPORTED CALLING BACK CALL FROM BD COM OUTGOING CALL. STATED HAS A 3RD SYRINGE FROM THIS SAME BOX TO REPORT. HAS 2 OUT OF 3 SYRINGES TO RETURN WITH SAME ISSUES. NEEDLE HUB STAYS IN SHIELD WHEN SHIELD REMOVED. OBTAINED THE MAILING INFO TO GET PRODUCTS BACK WITH MAILKIT AND VOUCHER. NO HARM. ISSUE IS THAT THE NEEDLE TIP SEPARATES WITH THE CAP WHEN YOU REMOVE THE CAP FROM THE BARREL. THIS HAS HAPPENED ON TWO SYRINGES FROM THE SAME BAG ALREADY. POTENTIAL HARM: IF YOU DO NOT HAVE EXTRA SYRINGES YOU WOULD BE IN A SITUATION WHERE YOU COULD NOT ADMINISTER YOUR INSULIN. A SAMPLE DEFECT IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 8MM 90 BX 450 MO HUB SEPARATED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328291 BATCH NO. 0090638. IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM SYRINGE. VERBATIM: FROM PHONE CALL ON 2020-12-03 12:29:32: CONSUMER REPORTED CALLING BACK CALL FROM BD COM OUTGOING CALL. STATED HAS A 3RD SYRINGE FROM THIS SAME BOX TO REPORT. HAS 2 OUT OF 3 SYRINGES TO RETURN WITH SAME ISSUES. NEEDLE HUB STAYS IN SHIELD WHEN SHIELD REMOVED. OBTAINED THE MAILING INFO TO GET PRODUCTS BACK WITH MAILKIT AND VOUCHER NO HARM. ISSUE IS THAT THE NEEDLE TIP SEPARATES WITH THE CAP WHEN YOU REMOVE THE CAP FROM THE BARREL. THIS HAS HAPPENED ON TWO SYRINGES FROM THE SAME BAG ALREADY. POTENTIAL HARM: IF YOU DO NOT HAVE EXTRA SYRINGES YOU WOULD BE IN A SITUATION WHERE YOU COULD NOT ADMINISTER YOUR INSULIN. A SAMPLE DEFECT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565368 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1